PMID- 21716130
OWN - NLM
STAT- MEDLINE
DCOM- 20120517
LR  - 20131121
IS  - 1536-4801 (Electronic)
IS  - 0277-2116 (Linking)
VI  - 54
IP  - 1
DP  - 2012 Jan
TI  - Pharmacokinetics and safety of dexlansoprazole MR in adolescents with symptomatic 
      GERD.
PG  - 41-7
LID - 10.1097/MPG.0b013e31822a323a [doi]
AB  - OBJECTIVES: Dexlansoprazole MR 30  mg once daily (QD) is approved in adults for 
      the treatment of symptomatic nonerosive gastroesophageal reflux disease (GERD) 
      and maintenance of healed erosive esophagitis (EE); 60  mg is approved for 
      healing EE. The present study assesses the pharmacokinetic (PK) profile and 
      safety of dexlansoprazole MR in adolescent patients. PATIENTS AND METHODS: Phase 
      1, open-label, parallel-group, multicenter study in male and female adolescents 
      (12-17 years) with GERD. Patients were randomized to receive dexlansoprazole MR 
      (30 or 60  mg, QD) for 7 days. Blood samples to determine dexlansoprazole plasma 
      concentrations were drawn over a 24-hour period after dosing on day 7. 
      Dexlansoprazole plasma concentrations and PK parameters were summarized by dose 
      group. Safety assessments included monitoring of adverse events (AEs). RESULTS: 
      Thirty-six patients (mean age 14.6 years), 14 boys and 22 girls, were randomized, 
      with PK data available for 35 patients. The overall exposure of dexlansoprazole 
      after administration of the 60-mg capsule was slightly less than double the 
      exposure from the 30-mg capsule. Cmax (691 and 1136  ng/mL) and area under the 
      plasma concentration time curve (2886 and 5120  ng . h/mL) values for the 30- and 
      60-mg doses, respectively, were similar to results from previous phase 1 studies 
      in healthy adults. Twelve of 36 patients (33.3%) experienced a total of 21 
      treatment-emergent AEs. All of the AEs were considered to be of mild severity. 
      CONCLUSIONS: The PK data for dexlansoprazole MR 30- and 60-mg capsules in 
      adolescent patients with symptomatic GERD were similar to those in healthy 
      adults. Both doses were well tolerated.
FAU - Kukulka, Michael
AU  - Kukulka M
AD  - Takeda Global Research & Development Center, Inc, Deerfield, IL 60015, USA. 
      michael.kukulka@tgrd.com
FAU - Wu, Jingtao
AU  - Wu J
FAU - Perez, Maria Claudia
AU  - Perez MC
LA  - eng
SI  - ClinicalTrials.gov/NCT00847210
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - J Pediatr Gastroenterol Nutr
JT  - Journal of pediatric gastroenterology and nutrition
JID - 8211545
RN  - 0 (2-Pyridinylmethylsulfinylbenzimidazoles)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0K5C5T2QPG (Lansoprazole)
RN  - UYE4T5I70X (Dexlansoprazole)
SB  - IM
MH  - 2-Pyridinylmethylsulfinylbenzimidazoles/adverse 
      effects/*pharmacokinetics/therapeutic use
MH  - Adolescent
MH  - Area Under Curve
MH  - Child
MH  - Dexlansoprazole
MH  - Esophagitis/*drug therapy/etiology
MH  - Female
MH  - Gastroesophageal Reflux/complications/*drug therapy
MH  - Humans
MH  - Lansoprazole
MH  - Male
MH  - Proton Pump Inhibitors/adverse effects/*pharmacokinetics/therapeutic use
EDAT- 2011/07/01 06:00
MHDA- 2012/05/18 06:00
CRDT- 2011/07/01 06:00
PHST- 2011/07/01 06:00 [entrez]
PHST- 2011/07/01 06:00 [pubmed]
PHST- 2012/05/18 06:00 [medline]
AID - 10.1097/MPG.0b013e31822a323a [doi]
PST - ppublish
SO  - J Pediatr Gastroenterol Nutr. 2012 Jan;54(1):41-7. doi: 
      10.1097/MPG.0b013e31822a323a.